The Government Does Not Conduct Its Own Clinical Trials For Covid-19 Vaccines Other Than Sinovac

JAKARTA - Head of the Food and Drug Supervisory Agency (BOPM) Penny K. Lukito said the government had not conducted clinical trials of the COVID-19 vaccine other than the Sinovac brand which would be used in Indonesia.

Other vaccines to be used in Indonesia include AstraZeneca, China National Pharmaceutical Group Corporation (Sinopharm), Moderna, Novavax, Pfizer and BioNTech, and those produced by PT Bio Farma, namely the Merah Putih vaccine.

"For other vaccines that will be carried out in Indonesia, there is no need for further clinical trials," Penny said in a virtual press conference, Friday, January 8.

However, BPOM will still issue emergency use authorization (EUA) for other vaccines. However, this emergency permit does not require the results of clinical trials conducted by state-owned PT Bio Farma.

According to Penny, BPOM is sufficient to obtain emergency permit data from a number of vaccine producing countries that have conducted their own clinical trials, such as the United States, Britain and other countries in Europe.

"From the EUA that have been given by these countries, we are only given complete data, linked in their registration process," said Penny.

"These are countries that have received a reliance program with Indonesia, so there are aspects of confidence and speed in granting permits. Within a maximum of 20 working days, the EUA will soon be out," he continued.

For information, the government has secured around 400 million doses of four types of COVID-19 vaccines from various countries. There are 5 vaccine procurement routes, namely 4 with bilateral channels and 1 multilateral route.

The COVID-19 vaccines from bilateral procurement include Sinovac, Novavax, AstraZeneca, and BioNTech Pfizer. Meanwhile, the multilateral COVID-19 vaccine will collaborate with the international vaccine organization GAVI.